Quality of Life of Caregivers and Patients Suffering From Multiple System Atrophy

Not Applicable

• Conditions: Multiple System Atrophy
• Interventions: Behavioral: Multimodal intervention

• Registration Number: NCT04965922
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder that cause as other neurodegenerative diseases profound declines in functioning and thus, require caregiving for assistance with daily living. The aim of the study is to evaluate the effect of a multimodal intervention as proposed by the NYU Caregiver Counseling and Support Intervention (NYUCI) on the quality of life of patients and their caregivers.

Detailed Description

Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder, which is characterized by a variable combination of parkinsonism, cerebellar dysfunction, autonomic failure, and additional signs. No effective treatment is available. MSA patients have a poor prognosis with a median survival ranging between 6 and 10 years. MSA as other neurodegenerative diseases cause profound declines in functioning ; thus, many patients require caregivers for assistance with daily living. Caregiving can also be extremely stressful, and many caregivers experience declines in mental health. All of these repercussions contribute to the deterioration of the caregiver's quality of life and they can have an impact on the patient, in particular, on the patient's survival. Improving quality of life is a major element and identifying effective targeted interventions would bring immediate and direct benefit to patients and their families. In this context, it seems that a multimodal intervention as proposed by the NYU Caregiver Counseling and Support Intervention (NYUCI) developed by Mittelman could contribute to improve disease management and better coping with daily living difficulties. The NYUCI strategy combines sessions of individual and family counseling, support group participation, and additional on-call telephone consultations in a flexible counseling approach that is tailored to each caregiving family

Study Timeline

• Study First Submitted: 2021-05-06
• Study Start: 2021-07-01
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-16
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05
• Primary Completion: 2022-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

Not provided

Exclusion Criteria

• Unified Multiple System Atrophy Rating Scale (UMSARS) IV > 4
• Absence of at least one close person

Caregivers Inclusion Criteria :

• Enable to answer to study scales and survey

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Multimodal intervention at inclusion	Multimodal intervention	Multimodal intervention will be proposed to Multiple system atrophy patients and their caregivers.
Multimodal intervention at 6 month	Multimodal intervention	Multimodal intervention will be proposed to Multiple system atrophy patients and their caregivers.

Primary Outcome Measures

Name	Time	Method
Multiple System Atrophy Quality of Life (MSA-QoL) Score	12 month	Score of emotional and social sub-dimension of the MSA Quality of Life scale. Quality of life questionnaire to collect the level of difficulty experienced by the patient (from no problem to extreme problem) during the 4 weeks preceding the interview on activities such as: moving; walking; maintaining balance; speak; feed oneself. It also assesses the patient's feelings about his illness.

Secondary Outcome Measures

Name	Time	Method
State Trait Inventory Anxiety (STAI) Score	6 month	Anxiety assessment. 2 scales of 20 questions used to assess how subjects feel at the time and generally. Score \> 65 means high anxiety ; Score \< 35 means low anxiety
Unified Multiple System Atrophy Rating Scale (UMSARS) I	6 month	(0=no disorder, 48=severe disorders): Is an assessment of daily life activities via 12 12 items scale used to assess language, writing, autonomy , walking and the presence of possible urinary, sexual or intestinal disorders. (0=no disorder, 48=severe)
Center for Epidemiologic Sutdies-Depression (CESD) Score	6 month	20 items scale used to assess the existence of a depressive syndrome. Scores less than 15 does not indicate any depressive disorder Scores between 15 and 21 are indicative of mild to moderate depression. Scores above 21 are consistent with the existence of severe/ major depression
Unified Multiple System Atrophy Rating Scale (UMSARS) II	6 month	Motor examination based on 14 items that allow to evaluate in particular facial expression, oculomotricity, oral expression, tremors or walking. 0=no disorder, 56=severe disorders
Zarit Scale score	6 month	Assesses caregiver burden. 22 item scale with total score ranging from 0 to 88. Score 20 mean zero load - Score \> 60 means severe load
Multiple System Atrophy Quality of Life (MSA-QoL) Score	6 month	Score of other sub-dimension of the MSA Quality of Life scale. The MSA-QoL questionnaire is composed of three different subscales: motor (14 items), non-motor (12 items) and emotional/social (14 items). The response options for each question range from 0 (no problem) to 4 (extreme problem) with higher total scores reflecting more impaired quality of life. The MSA-QoL also includes a visual analogue scale (VAS) of how satisfied patients feel (range 0-100, with lower scores indicating lower quality of life).
Montreal Cognitive Assessment (MoCA) Score	6 month	evaluates short-term memory, visuospatial skills, executive functions, attention, concentration, work memory, language, abstraction, computation, and time and space orientation. Cognitive impairment is assessed by the score on 30 points (27-30: no cognitive impairment; 21-26: mild).
Family Relations Index (FRI)	6 month	27 items used to assess family functioning : family cohesion, verbalization of feelings and family conflict.
Unified Multiple System Atrophy Rating Scale (UMSARS) III	6 month	Blood pressure and heart rate measurements in the lying and standing position for 10 min every minute.
Unified Multiple System Atrophy Rating Scale (UMSARS) IV	6 month	Assessment of the disability from 1 to 5. 1 = completely independent ; 5 = totally dependent

Trial Locations

Locations (1)

CHU Bordeaux; 🇫🇷 Bordeaux, France